Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus Disease
Brief summary
SPOCS is an international, multicenter, prospective observational cohort study with bi-annual study visits over a 3-year follow-up designed to systematically describe the comprehensive SLE patient-journey regarding clinical features, disease progression and treatment patterns, SLE outcomes, health status assessments (PROs), and health care resource utilization (HCRU) in a general population of moderate-to-severe SLE patients.
Detailed description
SPOCS is an international, multicenter, prospective observational cohort study with bi-annual follow-up over 3-years maximum follow-up of patients with SLE confirmed by American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) classification criteria, who have moderate-to-severe disease by SLEDAI-2K criteria (Modified SLEDAI-2K score ≥4 and/or SLEDAI-2K score ≥6 points, at least one life-time positive serology of anti-nuclear antibody (ANA) or double-stranded deoxyribonucleic acid antibody (dsDNA), and 6-month minimum treatment duration with systemic SLE treatment beyond NSAIDS and analgesics. Participants will be followed as per local routine clinical practice. SPOCS is an observational study with no requirement for protocolized treatment interventions.
Interventions
OTHERStandard of Care
Participants will be followed as per local routine clinical practice
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
Patients must meet the following criteria for enrollment in SPOCS: * Adult patients aged 18 years or older * Physician confirmation that patient meets ACR or SLICC SLE classification criteria * Current or historic positive serology of ANA or dsDNA * Minimum treatment duration of 6 months for active SLE with systemic SLE treatment beyond NSAIDs and analgesics * Moderate-to-severe SLE; SLEDAI-2K Criteria: Modified SLEDAI-2K score ≥4 and/or SLEDAI-2K score ≥6. The Modified SLEDAI-2K is the SLEDAI-2K assessment score without the inclusion of points attributable to any urine or laboratory results including immunologic measures and lupus headache. * Patient and/or representative(s) who understands the requirements of the study and provides written informed consent.
Exclusion criteria
Patients meeting any of the following criteria will be determined to be ineligible for enrollment in SPOCS: * Patients actively enrolled in interventional trials involving investigational agents * Patient with active severe lupus nephritis with a history of a renal biopsy in the last year showing active class III or class IV +/- class V lupus nephritis and/or urine protein:creatinine ratio \>1mg/mg based on random urine collection. * Patients unable to complete study measures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity | 6, 12, 18, 24, 30 and 36 months of follow-up | Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score and score change from Baseline in patients with high and/or low status interferon 1 gene signature at Baseline after 6, 12, 18, 24, 30 and 36 months of follow-up. |
| Healthcare resource utilization including direct and indirect costs | 12, 24 and 36 months of follow-up | Mean annual global healthcare cost related to SLE in patients with high and/or low status interferon 1 gene signature at Baseline after 12, 24 and 36 months of follow-up. |
| Patient reported health outcomes | 6, 12, 18, 24, 30 and 36 months of follow-up | Total 36-Item Short Form Health Survey (SF-36) score and score change from Baseline in Physical Component Score (PCS) and Mental Component Score (MCS) in patients with high and/or low status interferon 1 gene signature after 6, 12, 18, 24, 30 and 36 months of follow-up. SF-36 survey covers eight domains of well-being: physical functioning, role limitations, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health combined into PCS and MCS, two summary scores of SF-36 survey. |
| Organ damage burden | 12, 24 and 36 months of follow-up | Mean score for Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR DI) and change from Baseline in SLICC/ACR DI for total score and individual components scores in patients with high and/or low status interferon 1 gene signature at Baseline after 12, 24 and 36 months of follow-up |
| Medical events of special interest | up to 36 months | Incidence and prevalence of individual medical events of special interest in patients with high and/or low status interferon 1 gene signature at Baseline after 12, 24 and 36 months of follow-up. |
Countries
Australia, Canada, France, Germany, Italy, Spain, United Kingdom, United States
Outcome results
None listed